Sealing cushion for a protective face mask

ABSTRACT

Most protective masks are not designed to follow individual facial contours and have a limited ability to adjust to various facial sizes and shapes. A sealing cushion for use with surgical face masks and the like has a pliant body with a tacky surface and a wire embedded within, which together create a frame-like structure having a central aperture. The wire encased within the body of the cushion allows the apparatus to be shaped and fitted to the contours of the face to create a substantially airtight seal between the face and the mask. The sealing cushion can prevent or reduce entry of airborne contaminants around the sides and edges of the mask.

FIELD OF THE INVENTION

The present invention relates in general to the passage of aerosolized viruses and other small airborne microorganisms around the barrier of a protective mask, and in particular to an apparatus for use with a face mask which can create a substantially airtight seal between the mask and the face.

BACKGROUND OF THE INVENTION

Due to the COVID-19 pandemic of 2020 the wearing of protective masks has become part of daily life, along with frequently washing hands and social distancing. The Center for Disease Control and the World Health Organization confirm that protective masks can significantly decrease the chances of asymptomatic or pre-symptomatic transmission of the coronavirus that causes COVID-19 (SARS-CoV-2). This virus and other microorganisms can be transmitted by saliva droplets and respiratory aerosols released when an infected individual talks, coughs or sneezes. As a result, access to appropriate personal protection equipment including face masks, face shields and gowns is of utmost importance for health care workers. In addition, it is currently recommended that all individuals wear a protective mask when they are around people they do not live with, and in public settings where social distancing can be difficult.

Protective face masks such as those worn by surgeons and other surgical and anesthesia staff are generally soft, lightweight, loose-fitting disposable masks made of woven cloth or a non-woven synthetic material. Due to the recent COVID-19 pandemic, such protective masks have also been required to be worn by anyone in a public setting because they can be effective barriers to large droplets and large particles present in the inhaled air. To reduce fogging of glasses or goggles, most surgical masks routinely include a nosepiece in the form of a deformable metal strip that helps to fit the upper edge of the mask to the contour of the nose. Nevertheless, despite the barrier they provide, most protective masks have a limited ability to adjust to different facial sizes and shapes. Gaps and openings between the nose and cheeks are almost invariably formed as a result of facial muscular movement. Since most masks are not able to accurately follow individual facial contours, they typically allow inhaled air to bypass the barrier provided by the mask, which can lead to the transmission of viruses and other microorganisms residing in the aerosolized respiratory droplets of others.

The N-95 mask offers more protection than a typical protective mask because it fits tightly to the user's face and it is made of a specialized mesh of non-woven fibers which can filter at least 95% of small airborne particles. A leak test is required each time the mask is donned. While useful, N-95 masks are expensive for daily non-medical purposes, can be in short supply, and should be reserved for health care providers. In fact, to clarify that N-95 masks should not be the norm for public use, the Center for Disease Control has recently modified its guidelines on protective masks, with the inclusion of homemade cloth or fabric masks to be worn in public areas.

Considering the above, it is apparent that there remains an unresolved need to prevent aerosolized microorganisms from passing around the barrier provided by a typical protective face mask. It would therefore be advantageous to provide an improved means to seal a protective face mask to a wearer's face, such that it would be useful to provide an apparatus in the form of a pliant and tacky facial cushion for use with a protective face mask that can create a substantially airtight seal between the mask and the face. It would also be advantageous if the apparatus could be used by people with vastly different facial features. It would also be beneficial if the apparatus were inexpensive and reusable.

SUMMARY OF THE INVENTION

Briefly stated, the present invention is directed to an apparatus for creating a seal between a user's face and a protective face mask, so that most of the air entering and exiting the mask passes through the material of the mask, with minimal leakage around the sides and edges of the mask.

One aspect of the invention provides an apparatus for use with a protective face mask, the apparatus comprising: (a) a body made of a pliant and tacky material; and (b) a wire embedded within the body, wherein the body and the wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of a user.

Another aspect of the invention provides a soft yet moldable sealing cushion for use with a protective face mask, the sealing cushion comprising: (a) a body made of a pliant and tacky material, the body including a first tacky side for adhering to the inside surface of a protective face mask and a second tacky side for adhering to a user's face; and (b) a wire embedded within the body, wherein the body and the wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of a user.

Another aspect of the invention provides a method of donning a protective face mask, the method comprising the steps of: (a) providing a sealing cushion for use with a protective face mask, the face mask comprising a cover portion including an outside surface and an inside surface and a securing element, the sealing cushion comprising a body made of a pliant and tacky material, the body including a first tacky side for adhering to the inside surface of the cover portion of the mask and a second tacky side for adhering to a user's face; and a wire embedded within the body, wherein the body and the embedded wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of the user; (b) adhering the first tacky side of the body of the sealing cushion to the inside surface of the cover portion of the mask; (c) placing the mask with the sealing cushion over the user's mouth and nose; (d) securing the mask to the user's head with the securing element; and (e) applying gentle pressure to the outside surface of the mask to further adhere the first tacky side of the cushion to the inside surface of the mask as well as to adhere the second tacky side of the cushion to the user's face around the mouth and nose.

The inventive apparatus can be used to create a substantially airtight seal between the mask and the user's face and can prevent or reduce entry of aerosolized microorganisms through gaps or openings at the sides and edges of the mask. The apparatus can be reusable, and is intended to be used with any soft, protective mask.

The nature and advantages of the present invention will be more fully appreciated after reviewing the accompanying drawings, detailed description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description given below, explain the principles of the invention.

FIG. 1 is a typical protective mask intended for use with the inventive apparatus;

FIG. 2 is a perspective view of one embodiment of the inventive apparatus;

FIG. 3 is a perspective view of the apparatus of FIG. 2 positioned and adhered to the inside surface of the face mask of FIG. 1;

FIG. 4 is a perspective view of the apparatus of FIG. 2 positioned and adhered to the inside surface of the face mask of FIG. 1 after the apparatus has been shaped to fit a user's face.

DETAILED DESCRIPTION OF THE INVENTION

Looking at FIGS. 1-4, a typical protective face mask 10 for use with the present invention is generally a soft, lightweight, loose-fitting face mask such as those worn by surgeons and other surgical and anesthesia staff in hospital settings. The mask typically is constructed of a cover portion or body 15, made of woven cloth or a non-woven synthetic material, and at least one type of securing element 16, such as tie straps (illustrated), ear loops, elastic bands, hook and loop connections to a hair cap, etc. The mask 10 includes an outside surface 12 (see FIG. 1) which may have a fluid-repellant layer, and an inside surface 14 (see FIGS. 3, 4) which may have an absorbent layer. The mask 10 may be of the disposable type designed for a single use, or of the reusable type which can be reused by washing. The cover portion or body 15 of the mask covers at least the mouth and nostrils of the wearer when secured to the head.

As noted above, while masks are useful for preventing transmission of airborne particles, small gaps or openings between the nose and cheeks are almost invariably formed because of facial muscular movement. The inventive sealing cushion 20 illustrated in FIGS. 2-4 can create a seal between the mask and the user's face, and thus can be used with the mask to reduce or prevent the passage of airborne viruses or bacteria residing in aerosolized respiratory secretions. A preferred embodiment of an apparatus 20 according to the present invention is shown in FIGS. 2-4 as a sealing cushion 20 which includes a body 22 having a thin metal cable or wire 24 embedded within. As best appreciated from viewing FIG. 2, the body 22 and the wire 24 together define a substantially rectangular moldable frame-like structure 20 having a central aperture 26. The inside border or perimeter of the body defines the central aperture 26, which is intended for fitting around the mouth and nose of the user's face, and its outside border has generally rounded corners.

The body 22 of the inventive cushion is manufactured to be pliant and to have a pair of opposing application surfaces or sides 25, 27 which are tacky to the touch. Although the cushion 20 and its central aperture 26 are generally rectangular in shape, as illustrated in FIG. 4 the frame-like shape of the cushion 20 can be manipulated, curved, shaped, and/or fitted between the mask and the face. The tacky sides 25, 27 of the body 22 are physically identical and each can adhere to the inside surface of the mask as well as to the face. However, for orientation purposes the tacky sides can be designated as a first, or mask side 25 (see FIG. 2) and a second, or face side 27 (see FIGS. 3 and 4). For example, adherence of the first tacky side 25 to the inside surface 14 of the mask followed by molding and adherence of the second tacky side 27 to the contours of the face can seal the central aperture 26 around the mouth and the nose. If the central aperture 26 is centered in the mask body 15 (see FIGS. 3 and 4) and the user's mouth and nose are centered within the central aperture 26, substantially all the inhaled and exhaled air will pass through the cover portion 15 of the mask and through the central aperture 26, with minimal leakage around the sides and edges of the mask.

The tacky surfaces 25, 27 of the body 22 can be made of a soft silicone material such as Ecoflex 00-30, or a clear liquid silicone rubber (LSR) material. Silicones are inert, synthetic compounds varying in form from oil to hard resins. Soft silicones are a particular family of solid silicones which are known to be both pliant and tacky. The pliant property of soft silicones allows the cushion body 22 to be soft and flexible so that it can be easily bent, formed, shaped, or molded, such that the cushion can conform to subtle surface variations of the human face. The tacky property of soft silicones provides a tendency of the surfaces 25, 27 to stick to the skin as well as to the mask at ambient temperatures. For example, soft silicone bandages or dressings have been used in place of typical adhesive bandages in patients who have friable skin, such as the elderly or those with a skin condition (e.g. epidermolysis bullosa). In addition, while soft silicones reversibly and gently adhere to the skin, they have low toxicity and are not absorbed into the body, such that adverse reactions are rare.

The wire 24 embedded in the body 22 of the cushion is useful for adding structure to the pliant body so that the cushion can be more efficiently molded and fitted to a particular user's face. The wire 24 is typically a thin, rounded metallic wire, such as a stainless steel or aluminum wire. As a non-limiting example, a suitable diameter for the wire ranges from about 0.5 mm to about 1.3 mm (about 16 gauge to about 24 gauge). The wire 24 is typically centrally encased in the body 22 as illustrated and is particularly useful for closing any gaps between the user's nose and cheeks. Because of variations in individual nose shapes and sizes, as well as nasal bridge height, the nasal area of the face is predisposed to air entry around the top edge or sides of a protective mask. The inventive cushion 20 can diminish or prevent leakage around the sides and edges of the mask by creating a substantially airtight seal between the user's face and the mask.

As can be appreciated by viewing FIG. 4, the embedded wire 24 can be used to distort the shape of the generally rectangular central aperture 26 to fit around the individual contours of the mouth and nose of the user. Noticeable curvatures can be imparted to the pliant and tacky body 22, aided by the structural support provided by wire 24. In use, the sealing cushion 20 can first be positioned within and adhered to the inside surface 14 of the face mask 10, and with the sealing cushion 20 in place the mask can then be positioned over the mouth and nose. The mask is then tied, strapped, or otherwise secured to the head with a securing element 16.

Once the mask is secured to the head by the tie straps 16, any gaps and openings around the sides and edges of the mask can be closed so that most of the inhaled and exhaled air will pass through the central aperture 26 and thus through the cover portion 15 of the mask. Specifically, gentle pressure can be manually applied to the cushion by the user through the outside surface 12 of the mask to ensure that the first tacky side 25 of the cushion is adhered to inside surface 14 of the mask and that the second tacky side 27 of the cushion is adhered to contours of the face, with the central aperture 26 being centered over the mouth and nose. Because of the tacky nature of the body 22 a reversible seal will be formed between the cushion and the mask and between the cushion and the surface of the face.

The body 22 of the cushion can range from ⅛ (one-eighth) inches to ⅜ (three-eighths) inches thick, and the outer perimeter can range from 3 inches to 5 inches in width, and from 2 inches to 4 inches in height. The inner perimeter of the frame, defining the central aperture 26, can range from 2 inches to 4 inches in width, and from 1.5 inches to 2.5 inches in height. The body 22 may be manufactured using compression molding, injection molding or thermoforming; for example, it may be formed in a mold with a polished surface to provide a smooth exterior surface. In addition to soft silicone, the body may be constructed from other soft, flexible materials, e.g., a thermoplastic elastomer, or closed cell impermeable foam, so long as the material is pliant and tacky, and moldable when the wire is encased within. Whether a soft silicone material or another material, the body should be chemically inert, water repellant and biocompatible. The sealing cushion can be designed to fit most adult and child sized protective masks, and is intended to be reusable and able to be cleaned with soap, alcohol wipe, UV light, etc.

The present invention can enhance the effectiveness of a protective face mask by creating a seal under the mask around the mouth and nose to prevent or reduce entry of airborne contaminants passing around the mask body through gaps or openings located at the sides and edges of the mask. While the seal created may not ensure that all of the inhaled/exhaled air passes through the central aperture, experience with its use has demonstrated reduced leakage of inhaled and exhaled air around the mask body with proper use of the inventive sealing cushion.

While the present invention has been illustrated by the description of particular embodiments in considerable detail, the above description is not intended to restrict or limit the scope of the appended claims to such detail. Additional advantages and modifications will be readily apparent to those skilled in the art without departing from the concept or scope of the invention. 

What is claimed is:
 1. An apparatus for use with a protective face mask, the apparatus comprising: a) a body made of a pliant and tacky material; and b) a wire embedded within the body, wherein the body and the wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of a user.
 2. The apparatus of claim 1, wherein the body includes a first tacky side for adhering to the inside surface of a protective face mask and a second tacky side for adhering to the user's face.
 3. The apparatus of claim 1, wherein the body is made of a soft silicone material and the wire is made of aluminum.
 4. The apparatus of claim 1, wherein the diameter of the wire is between 0.5 mm and 1.3 mm.
 5. The apparatus of claim 1, wherein the body is between ⅛ (one-eighth) inches and ⅜ (three-eighths) inches thick, between 3 inches and 5 inches in width, and between 2 inches and 4 inches in height, and wherein the central aperture is between 2 inches and 4 inches in width and between 1.5 inches and 2.5 inches in height.
 6. A soft yet moldable sealing cushion for use with a protective face mask, the sealing cushion comprising: a) a body made of a pliant and tacky material, the body including a first tacky side for adhering to the inside surface of a protective face mask and a second tacky side for adhering to a user's face; and b) a wire embedded within the body, wherein the body and the wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of a user.
 7. The sealing cushion of claim 1, wherein the body is made of a soft silicone material and the wire is made of aluminum.
 8. The sealing cushion of claim 1, wherein the diameter of the wire is between 0.5 mm and 1.3 mm.
 9. The sealing cushion of claim 1, wherein the body is between ⅛ (one-eighth) inches and 3/8 (three-eighths) inches thick, between 3 inches and 5 inches in width, and between 2 inches and 4 inches in height, and wherein the central aperture is between 2 inches and 4 inches in width and between 1.5 inches and 2.5 inches in height.
 10. A method of donning a protective face mask, the method comprising the steps of: a) providing a sealing cushion for use with a protective face mask, the face mask comprising: i) a cover portion including an outside surface and an inside surface; and ii) a securing element, the sealing cushion comprising: i) a body made of a pliant and tacky material, the body including a first tacky side for adhering to the inside surface of the cover portion of the mask and a second tacky side for adhering to a user's face; and ii) a wire embedded within the body, wherein the body and the embedded wire together define a moldable frame including a central aperture for shaping and fitting around the mouth and nose of the user; b) adhering the first tacky side of the body of the sealing cushion to the inside surface of the cover portion of the mask; c) placing the mask with the sealing cushion over the user's mouth and nose; d) securing the mask to the user's head with the securing element; and e) applying gentle pressure to the outside surface of the mask to further adhere the first tacky side of the cushion to the inside surface of the mask as well as to adhere the second tacky side of the cushion to the user's face around the mouth and nose.
 11. The method of claim 10, wherein the securing element of the face mask is selected from the group consisting of ear loops, tie straps, elastic bands, and hook and loop connections to a hair cap.
 12. The method of claim 10, wherein the body of the sealing cushion is made of a soft silicone material and the wire is made of aluminum.
 13. The method of claim 10, wherein the diameter of the wire is between 0.5 mm and 1.3 mm.
 14. The method of claim 10, wherein the body of the sealing cushion is between ⅛ (one-eighth) inches and ⅜ (three-eighths) inches thick, between 3 inches and 5 inches in width, and between 2 inches and 4 inches in height, and wherein the central aperture is between 2 inches and 4 inches in width and between 1.5 inches and 2.5 inches in height.
 15. The method of claim 10, wherein a substantially airtight seal is created between the mask and the user's face to reduce entry of aerosolized microorganisms through gaps or openings at the sides and edges of the mask.
 16. The method of claim 10, wherein the cushion is reusable. 